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The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants

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ClinicalTrials.gov Identifier: NCT03310853
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
OVO R & D
Information provided by (Responsible Party):
Lallemand Health Solutions

Tracking Information
First Submitted Date  ICMJE September 28, 2017
First Posted Date  ICMJE October 16, 2017
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE October 23, 2017
Estimated Primary Completion Date October 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
Number of diagnosed infections in pregnant women [ Time Frame: up to 12 weeks ]
This includes any viral, bacterial and fungal infection (e.g. bacterial vaginosis, candidiasis, urinary tract infection, mastitis, cold, flu, gingivitis, etc.). A vaginal swab and saliva sample will be taken at every visit on site throughout pregnancy. The vaginal swab will be used for the detection of Bacterial Vaginosis and Candidiasis. Other required swab samples will be collected if an infection occurs (e.g. vaginal, mouth, throat, nose, etc.). If an infection is suspected by a participant in-between a scheduled visit, the participant will come on site to be checked by a doctor. If the participant is subsequently diagnosed with an infection, a saliva sample will need to be taken at this time.
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
Number of diagnosed infections in pregnant women [ Time Frame: Measured 6 times up to 12 weeks ]
This includes any viral, bacterial and fungal infection (e.g. bacterial vaginosis, candidiasis, urinary tract infection, mastitis, cold, flu, gingivitis, etc.). A vaginal swab and saliva sample will be taken at every visit on site throughout pregnancy. The vaginal swab will be used for the detection of Bacterial Vaginosis and Candidiasis. Other required swab samples will be collected if an infection occurs (e.g. vaginal, mouth, throat, nose, etc.). If an infection is suspected by a participant in-between a scheduled visit, the participant will come on site to be checked by a doctor. If the participant is subsequently diagnosed with an infection, a saliva sample will need to be taken at this time.
Change History Complete list of historical versions of study NCT03310853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • Levels of glucose, insulin, triglycerides and iron [ Time Frame: Measured 2 times up to 12 weeks ]
    Assessed via blood sample throughout the pregnancy
  • Vaginal mycobiota [ Time Frame: Measured 3 times up to 18 weeks ]
    Vaginal microbiome which includes bacteria, fungus and potentially other eukaryotic micro-organisms such as parasites or viruses. To be assessed with a vaginal swab during pregnancy and after delivery.
  • Inflammatory markers [ Time Frame: Measured up to 3 times in the 18 week time frame ]
    Assessing levels of both pro- and anti- inflammatory markers in the mother during pregnancy (through stool and blood samples) and after delivery (through breast milk sample).
  • Vaginal microbiota [ Time Frame: Measured 3 times up to 18 weeks ]
    Effects of the probiotic interventions on overall microbiota composition in the mother will be assessed. In addition, recovery of the probiotic strains in the vaginal samples will be assessed.
  • Premature rupture of membranes (PROM) [ Time Frame: Measured 1 time at week 12 ]
    Incidence of PROM on the probiotic versus the group
  • Levels of secretory immunoglobulin A (sIgA) in the mother [ Time Frame: Measured up to 4 times in the 18 week time frame ]
    Assessed via saliva samples throughout pregnancy and a breast milk sample after delivery.
  • Levels of secretory immunoglobulin A (sIgA) in the infant [ Time Frame: Measured 1 time up to18 weeks ]
    Assessed via stool sample after birth.
  • Gut microbiota in the mother [ Time Frame: Measured 3 times up to 18 weeks ]
    Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed.
  • Gut microbiota in the infant [ Time Frame: Measured 1 time up to 18 weeks ]
    Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed.
  • Stool frequency and consistency in the mother [ Time Frame: Self-reported, daily up to 18 weeks ]
    Assessed with the Bristol Stool Scale
  • Stool frequency and pattern in the infant [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    Assessed with the Amsterdam Infant Stool Scale
  • Weight in the mother [ Time Frame: Measured 3 times up to 18 weeks. Pre-pregnancy weight will also be noted via information collection on a demographic questionnaire. ]
    To assess change in body weight
  • Breast milk microbiota [ Time Frame: Measured 1 time up to 18 weeks ]
    Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the breast milk samples will be assessed.
  • Post-Partum Depression [ Time Frame: Measured 2 time up to 18 weeks ]
    To be assessed with the Edinburgh Postnatal Depression Scale
  • Infant's health status - NEC [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with NEC
  • Anthropometric measurements [ Time Frame: Measured 1 time up to 18 weeks. The infant's anthropometric measurements at birth will also be noted. ]
    Crown-heel length and head circumference
  • Weight in the infant [ Time Frame: Measured 2 times up to 18 weeks. ]
    To assess change in body weight
  • Crying time in the infant [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    To assess the mean daily crying time of infants
  • Colic in the infant [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    To asses the probability of an infant with colic
  • Sleep in the infant [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    Number of total hours and number of consecutive hours
  • Number of infections [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    To assess the number of infections
  • Skin diseases or conditions [ Time Frame: 1 year follow up phone call ]
    Skin diseases/conditions as well as the child's overall health status 1 year after birth will be assessed.
  • Infant's health status - jaundice [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with jaundice
  • Infant's health status - Hyperbilirubinemia [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with Hyperbilirubinemia
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • Levels of glucose, insulin, triglycerides and iron [ Time Frame: Measured 2 times up to 12 weeks ]
    Assessed via blood sample throughout the pregnancy
  • Vaginal mycobiota [ Time Frame: Measured 7 times up to 18 weeks ]
    Vaginal microbiome which includes bacteria, fungus and potentially other eukaryotic micro-organisms such as parasites or viruses. To be assessed with a vaginal swab during pregnancy and after delivery.
  • Type of delivery [ Time Frame: Measured 1 time at week 12 ]
    A vaginal versus cesarean delivery will be noted
  • Inflammatory markers [ Time Frame: Measured up to 3 times in the 18 week time frame ]
    Assessing levels of both pro- and anti- inflammatory markers in the mother during pregnancy (through stool and blood samples) and after delivery (through breast milk sample).
  • Vaginal microbiota [ Time Frame: Measured 7 times up to 18 weeks ]
    Effects of the probiotic interventions on overall microbiota composition in the mother will be assessed. In addition, recovery of the probiotic strains in the vaginal samples will be assessed.
  • Premature rupture of membranes (PROM) [ Time Frame: Measured 1 time at week 12 ]
    Incidence of PROM on the probiotic versus the group
  • Levels of secretory immunoglobulin A (sIgA) in the mother [ Time Frame: Measured up to 7 times in the 18 week time frame ]
    Assessed via saliva samples throughout pregnancy and a breast milk sample after delivery.
  • Levels of secretory immunoglobulin A (sIgA) in the infant [ Time Frame: Measured 1 time up to18 weeks ]
    Assessed via stool sample after birth.
  • Gut microbiota in the mother [ Time Frame: Measured 3 times up to 18 weeks ]
    Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed.
  • Gut microbiota in the infant [ Time Frame: Measured 1 time up to 18 weeks ]
    Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed.
  • Stool frequency and consistency in the mother [ Time Frame: Self-reported, daily up to 18 weeks ]
    Assessed with the Bristol Stool Scale
  • Stool frequency and pattern in the infant [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    Assessed with the Amsterdam Infant Stool Scale
  • Stress, anxiety and depression levels [ Time Frame: Self-reported, daily up to 18 weeks ]
    Assessed via daily diary input
  • Headache/Migraine severity [ Time Frame: Self-reported, daily up to 18 weeks ]
    Assessed via daily diary input
  • Nausea severity [ Time Frame: Self-reported, daily up to 12 weeks ]
    Measured during prenatal period only
  • Weight in the mother [ Time Frame: Measured 3 times up to 18 weeks. Pre-pregnancy weight will also be noted via information collection on a demographic questionnaire. ]
    To assess change in body weight
  • Breast milk microbiota [ Time Frame: Measured 1 time up to 18 weeks ]
    Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the breast milk samples will be assessed.
  • Post-Partum Depression [ Time Frame: Measured 1 time up to 18 weeks ]
    To be assessed with the Edinburgh Postnatal Depression Scale
  • Infant's health status - NEC [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with NEC
  • Anthropometric measurements [ Time Frame: Measured 1 time up to 18 weeks. The infant's anthropometric measurements at birth will also be noted. ]
    Crown-heel length and head circumference
  • Weight in the infant [ Time Frame: Measured 2 times up to 18 weeks. ]
    To assess change in body weight
  • Crying time in the infant [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    To assess the mean daily crying time of infants
  • Colic in the infant [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    To asses the probability of an infant with colic
  • Sleep in the infant [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    Number of total hours and number of consecutive hours
  • Number of infections [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    To assess the number of infections
  • Skin diseases or conditions [ Time Frame: 1 year follow up phone call ]
    Skin diseases/conditions as well as the child's overall health status 1 year after birth will be assessed.
  • Infant's health status - jaundice [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with jaundice
  • Infant's health status - Hyperbilirubinemia [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with Hyperbilirubinemia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants
Official Title  ICMJE The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants: a Randomized, Double-blind, Placebo Controlled Study
Brief Summary This phase 2 study evaluates the effect of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a health pregnancy. In addition, the effect of probiotics intake during pregnancy and breastfeeding on the infant's overall health status will be evaluated.
Detailed Description Throughout pregnancy women undergo many biological changes, including alterations in their microbiota. These infections can exacerbate pregnancy complications and increase the risk of preeclampsia and preterm birth. The present study aims to evaluate the potential effects of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a healthy pregnancy. Potential infections include but are not limited to influenza/colds, bacterial vaginosis, mastitis, candidiasis, urinary tract infection and gingivitis. Additionally, the benefits of probiotic intake by the mother on the infant during pregnancy and breastfeeding will be evaluated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pregnancy
Intervention  ICMJE
  • Dietary Supplement: Probiotic
    Dosing regimen of one capsule daily for a maximum of 18 weeks
  • Other: Placebo
    Dosing regimen of one capsule daily for a maximum of 18 weeks
Study Arms  ICMJE
  • Experimental: Probiotic
    Combination of two probiotic strains in one capsule
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: Placebo
    Non active ingredients in a capsule
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy pregnant women
  • Less than 28 weeks of gestation (3rd trimester)
  • ≥18 to <40 years old
  • Singleton gestation
  • Availability and willingness to come in for morning visits
  • Planning to breastfeed
  • Willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits
  • Willing to discontinue consumption of fermented foods (e.g. foods that contain probiotics such as Kefir, pickles, etc.) or probiotics (e.g. yogurts with live active cultures or probiotic supplements)
  • Able to provide informed consent

Exclusion Criteria:

  • Known gestational diabetes or diabetes type 1 or 2
  • Known blood/bleeding disorders
  • Known liver and kidney disorders
  • Known unstable cardiovascular diseases
  • Women with a personal history of or currently diagnosed with preeclampsia
  • Suffering from neurological diseases (e.g. Alzheimer's disease, Parkinson's disease, epilepsy, etc.)
  • Suffering from gastrointestinal diseases (e.g. gastric ulcers, Crohn's disease, ulcerative colitis, etc.)
  • Current symptoms of depression or experienced depressive symptoms in the past 2 years
  • Maternal history of second trimester loss
  • Women diagnosed HIV Positive or with Hepatitis B or C
  • Known fetal abnormality
  • Daily use of probiotic product within 2 weeks of the screening visit. The potential participant could be eligible to participate after a 2-week wash-out period
  • Use of any antibiotic drug within 1 month of screening. The potential participant could be eligible to participate after a 2-week wash-out period
  • Smoking, alcohol consumption or drug use during pregnancy
  • History of alcohol or substance abuse six months prior to screening
  • Allergies to milk, soy, or yeast
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sophie Leblanc 514-798-2000 ext 617 s.leblanc@cliniqueovo.com
Contact: Nelly Delouya 514-798-2000 ext 759 n.delouya@cliniqueovo.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03310853
Other Study ID Numbers  ICMJE MOM study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lallemand Health Solutions
Study Sponsor  ICMJE Lallemand Health Solutions
Collaborators  ICMJE OVO R & D
Investigators  ICMJE
Principal Investigator: Jacques Kadoch, MD OVO R & D
PRS Account Lallemand Health Solutions
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP